What is allowed, what is not, and how to stay clear of the line.
The reference for every regulatory question on this project: how the patient-facing agents avoid medical-device classification, how patient data stays compliant, and where models must run in-region. One principle holds it all together.
An AI operating layer for fertility and gynaecology clinics
Patient-facing agents handle education, intake, qualification, booking, follow-up, and routing, fed by neutral education properties (Fertility.ai, IVF.ai, Gynaec.ai). The agents are deliberately non-clinical. They route patients, they do not diagnose them.
Regulatory positioning is part of the product, not paperwork
Staying outside medical-device classification and inside data law is what makes the model defensible and deployable. This is the reference overview for any regulatory question on the project, kept current as the rules move.
Route, do not diagnose. Keep patient data where the law requires.
Medicly's agents never become a medical device, because they act on what a patient asks for, never on a clinical reading of their symptoms. That one choice holds across every market here. On data, identifiable patient information is handled under each country's privacy law, with model inference run in-region wherever residency rules require it. Everything below is the evidence behind that posture, by country, for both device law and data law.
Who should read what
This carries both a plain summary and the underlying detail. Start where your question sits.
The defensibility story: why non-clinical positioning is a moat, and how recent law moved for or against us.
What changed recentlyExactly what the agent will and will not do with a patient, and the line it never crosses.
The capability matrixWhat you are deploying, how patient data is handled, and where it is stored and processed.
Data privacy by marketThe named instruments per jurisdiction, the classification logic, and the rules to verify before signing.
Jurisdiction detailThe constraints that bind the build: language, the model split, residency tiers, and the pre-pilot checklist.
Hosting and operating rulesWhat changed recently
Device and data rules moved substantially across late 2025 and the first half of 2026. Each item is dated, with when it applies and what it means for Medicly.
- 202611 May 2026
UK: draft Medical Devices (Amendment) Regulations 2026
UK · MHRAConsultation now, adoption expected Dec 2026For Medicly: introduces Reg 19D against misleading or unsubstantiated promotional claims, a flag for any co-branded clinic content with implied efficacy. The new International Reliance Pathway can ease UK entry where an EU or FDA status already exists.
- Feb 2026
Australia: TGA guidance on AI software as a medical device
AU · TGAIn effect, clarifies existing lawFor Medicly: the strictest line of the six, so it sets the bar for the whole product. It explicitly names LLM chatbots that apply clinical triage protocols as in-scope devices. The non-clinical design stays out, provided the agent never reasons on symptoms on the patient path.
- 6 Jan 2026
US: FDA Clinical Decision Support final guidance
US · FDAFinal, in effectFor Medicly: loosened rules for clinician-facing tools, but still silent on patient-facing chatbots and symptom checkers. For a patient-facing use case the US line is effectively as strict as Australia.
- 202519 Nov 2025
EU: Digital Omnibus relief for the AI Act
EUProposed: standalone high-risk AI to 2 Dec 2027, device-embedded AI to 2 Aug 2028For Medicly: more runway if we ever touched device scope, but the dual MDR and AI Act burden still applies on misclassification. Our neutral education layer stays out regardless of the timeline.
- 13 Nov 2025
India: DPDP Rules 2025 notified
INPhased, full compliance by ~mid-2027For Medicly: the most actionable data change in the set. Consent, notice, and purpose-bound retention should be built in from the start. India allows cross-border transfer unless a destination is restricted, and has no separate sensitive-data tier. Where Significant Data Fiduciary thresholds are crossed, an annual DPIA and independent audit apply.
- 21 Oct 2025
India: CDSCO draft guidance on medical device software
IN · CDSCODraft, directionalFor Medicly: confirms the carve-out the product relies on. Administrative and appointment or booking software is explicitly outside device scope. The schedule or connect to a human, never decide output design keeps the system inside that carve-out.
- 10 Jun 2025
Australia: privacy reforms take effect
AU · OAICIn force; ADM transparency by Dec 2026For Medicly: a statutory tort for serious invasion of privacy is now live, raising the stakes on data handling. This reinforces keeping inference onshore under APP 8.
- 2 Jan 2025
UAE: Federal Decree-Law 38 of 2024 in force, EDE consolidation
AE · EDEIn force; EDE absorbed device functions through early 2026For Medicly: a reliance-based device regime. Combined with Federal Law 2 of 2019, health-data localisation is effectively mandatory, so identifiable patient inference must run in-country. This is the strictest residency market of the six.